← FDA DRUG APPROVALS

FDA NDA · NDA017116

METHADOSE

methadone hydrochloride

Sponsor: SPECGX LLC

APPLICATION
NDA017116
TYPE
NDA
ORIGINAL APPROVAL
1973-03-14
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Prescription

Products

METHADOSE · ReferencePrescription
METHADONE HYDROCHLORIDE 10MG/ML · CONCENTRATE · ORAL

Approval history

2025-12-22Labeling · Supplement 48 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 45 · standard — Label ↗AP
2021-09-13Labeling · Supplement 43 · standard — Letter ↗AP
2021-06-02Labeling · Supplement 41 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 38 · standard — Label ↗AP
2018-02-01Labeling · Supplement 32 · standard — Label ↗AP
2016-12-16Labeling · Supplement 29 · standard — Letter ↗AP
2014-09-22Manufacturing (CMC) · Supplement 27 · standardAP
2014-06-02Manufacturing (CMC) · Supplement 26 · standardAP
2008-02-04Labeling · Supplement 21 · standard — Letter ↗AP
2005-08-03Manufacturing (CMC) · Supplement 19 · standard — Letter ↗AP
2005-08-03Manufacturing (CMC) · Supplement 18 · standard — Letter ↗AP
2005-05-26Labeling · Supplement 15 · standard — Letter ↗AP
2005-05-26Labeling · Supplement 16 · standard — Letter ↗AP
2002-03-27Manufacturing (CMC) · Supplement 14 · standard — Letter ↗AP
2000-04-03Manufacturing (CMC) · Supplement 13 · standardAP
1993-04-20Labeling · Supplement 12AP
1982-09-07Manufacturing (CMC) · Supplement 10 · standardAP
1981-11-25Manufacturing (CMC) · Supplement 9 · standardAP
1980-02-06Labeling · Supplement 7AP
1980-02-06Manufacturing (CMC) · Supplement 8 · standardAP
1977-02-11Labeling · Supplement 2AP
1976-08-06Manufacturing (CMC) · Supplement 1 · standardAP
1973-03-14Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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